Additional File 1 Sources of Depression Incidence Data
Additional file 1 – Sources of depression incidence data
Source / Sponsor / Doses, N's / P.I. / Locations / Duration / Drop-outs / Inclusion /ExclusionDerived from labeling information, Table 1, accessed July 10, 2007 [1] / Sanofi-Synthelabo / Zolpidem tartrate extended-release 12.5 mg: N=102 (depression N=2).
placebo: N=110 (depression N=0) / Not stated / Not stated / 3 weeks / Not stated / Notstated
Derived from labeling information, Table 2, accessed July 10, 2007 [1] / Sanofi-Synthelabo / Zolpidem tartrate extended-release 6.25 mg: N=99 (depressed mood N=1)
placebo: N=106 (depressed mood N=0) / Not stated / Not stated / 3 weeks / Not stated / Not stated
Derived from labeling information Table entitled Incidence of Treatment-Emergent Adverse Experiences in Long-term Placebo-Controlled Clinical Trials, accessed July 10, 2007[2] / Sanofi-Aventis / Zolpidem 5-10 mg. N=152 (depression = 2%, i.e., probably N=3)
placebo N=161 (depression = 1%, probably N=2) / Not stated / Not stated / 28-35 nights / Not stated / Not stated
Derived from FDA medical review Table 8.1.5.3.1, accessed July 16, 2007[3] / Wyeth-Ayerst / Zaleplon 5, 10, or 20 mg. N=786 (Depression 3%, presumably N=24)
Placebo N=277 (Depression 2%, presumably N=6) / Not stated / Not stated / 28 days / Not stated / Not stated
Derived from labeling information, Table 1, accessed July 16, 2007[4] / Sepracor / Eszopiclone 2 mg.N=104 (N=4 depressed) eszopiclone 3 mg.N=105 (N=1 depressed)
placeboN=99 (N=0 depressed) / Not stated / Not stated / 6 weeks / not stated / not stated
Derived from FDA medical review Table H6, accessed July 16, 2007[5] / Sepracor / Eszopiclone 3 mg.N=593 (N=27 depressions)
placeboN=195 (N=3 depressions) / Not stated[1] / Not stated / 6 mo. / Not stated[2] / Not stated[3]
Derived from FDA medical review Table 29, accessed July 16, 2007[6] / Takeda / Ramelteon <4 to 64 mgN=3594 (N=48 depressions)
placeboN=1370 (N=11 depressions)[4] / Not stated / Not stated / Not stated / Not stated / Not stated
References
1. AUGUST 29 2005: Ambien CR™: (zolpidem tartrate extended-release tablets) [
2. Full Prescribing Information [
3. Center for Drug Evaluation Application Number: 020859: Medical Review(s) [
4. LUNESTA™ (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg [
5. Center for Drug Evaluation and Research Approval Package for: Application Number 21-476: Medical Review(s) [
6. Center for Drug Evaluation and Research Application Number: 21-782: Medical Review [
[1]Appears to be the same as: Krystal AD, Walsh JK, Laska E et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep 2003;26(7):793-9.
[2] Krystal et al. stated that 360 (60.5%) of eszopiclone patients and 111 (56.6%) of placebo patients completed the study. Discontinuation due to depression was 2% in the eszopiclone group and 0% in the placebo group.
[3] According to Krystal et al., "Patients receiving a DSM IV diagnosis of primary insomnia and reporting a usual total sleep time less than 6.5 hours per night and/or a usual sleep latency of more than 30 minutes each night for at least 1 month prior to screening were eligible for randomization, provided they did not (1) meet criteria for a DSM-IV Axis I psychiatric diagnosis other than primary insomnia, sexual and gender-identity disorders, or Axis II personality disorders (excluded by medical history); (2) have a history of substance abuse or substance dependence; (3) consume more than 2 alcoholic beverages per day or more than 14 per week; (4) use any psychotropic, hypnotic, or other medications known to affect sleep or to be contraindicated for use with hypnotics; or (5) use over-the counter analgesics that contain caffeine or herbal supplements, including products with herbs, melatonin, or St. John’s Wort."
[4]A more limited subset were summarized in Table 6.1 of the document, in which the risk ratio for ramelteon was higher and significant (P<0.05).